Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the present study is to determine whether people receiving d-cycloserine and exposure therapy show different brain reactions to symptom provocation compared to people receiving placebo and exposure therapy.
D-cycloserine (DCS) is a partial N-methyl-D-aspartate (NMDA) receptor agonist that may improve or accelerate extinction learning. We will randomly assign people with snake phobia to receive DCS or placebo, and then provide all participants with exposure therapy. We will examine whether people receiving DCS and vs. placebo show different brain reactions to symptom provocation before and after exposure therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-cycloserine plus exposure therapy | Experimental | Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session |
|
| Placebo plus exposure therapy | Placebo Comparator | Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-cycloserine | Drug | 50 mg d-cycloserine, oral, 1 dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Snake Questionnaire (SNAQ) | 30-item self-report scale of severity of snake fear and avoidance Range: 0-30; higher values indicate greater fear severity | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician's Global Impression (CGI)-Severity | Clinician rating of global illness severity (at pre- and post-treatment) CGI-Severity range 1-7; higher scores indicate greater illness severity. | 2 weeks |
| Clinician's Global Impression (CGI)-Improvement |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Tolin, PhD | Hartford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Living/Hartford Hospital | Hartford | Connecticut | 06106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23059145 | Result | Nave AM, Tolin DF, Stevens MC. Exposure therapy, D-cycloserine, and functional magnetic resonance imaging in patients with snake phobia: a randomized pilot study. J Clin Psychiatry. 2012 Sep;73(9):1179-86. doi: 10.4088/JCP.11m07564. |
Not provided
Not provided
De-identified data will be made available upon request
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | D-cycloserine Plus Exposure Therapy | Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session |
| FG001 | Placebo Plus Exposure Therapy | Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | D-cycloserine Plus Exposure Therapy | Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session |
| BG001 | Placebo Plus Exposure Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Snake Questionnaire (SNAQ) | 30-item self-report scale of severity of snake fear and avoidance Range: 0-30; higher values indicate greater fear severity | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | D-cycloserine Plus Exposure Therapy | Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Mild nausea, resolved without intervention |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr David Tolin | Hartford Hospital | 860-545-7685 | david.tolin@hhchealth.org |
Not provided
| ID | Term |
|---|---|
| C562465 | Phobia, Specific |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003523 | Cycloserine |
| D007171 | Implosive Therapy |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Exposure therapy |
| Behavioral |
Single session graded in vivo exposure therapy, 60-180 minutes |
|
| Placebo | Drug | Single capsule of oral placebo, administered once 1 hr prior to exposure therapy |
|
Clinician rating of global illness severity (at post-treatment)
CGI-Improvement range 1-7; higher scores indicate poorer improvement; classified as responder if score = 1 or 2, nonresponder if score > 2
| 2 weeks |
Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Clinician's Global Impression (CGI)-Severity | Clinician rating of global illness severity (at pre- and post-treatment) CGI-Severity range 1-7; higher scores indicate greater illness severity. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Secondary | Clinician's Global Impression (CGI)-Improvement | Clinician rating of global illness severity (at post-treatment) CGI-Improvement range 1-7; higher scores indicate poorer improvement; classified as responder if score = 1 or 2, nonresponder if score > 2 | Posted | Number | participants | 2 weeks |
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Placebo Plus Exposure Therapy | Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session | 0 | 10 | 0 | 10 |
|
Not provided
Not provided
Not provided
| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |